[A21-128] Onasemnogene abeparvovec (spinal muscular atrophy) - Addendum to Commission A21-68

Last updated 04.11.2021

Project no.:
A21-128

Commission:
Commission awarded on 29.09.2021 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Head and nerves

Indication:

Patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene

Result of dossier assessment:

Unchanged after addendum:

  • SMA type 1: added benefit not proven.
  • SMA type 2: added benefit not proven.
  • SMA type 3: added benefit not proven.
  • Pre-symptomatic patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene: added benefit not proven.

Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

Federal Joint Committee (G-BA)

2021-11-04 A G-BA decision was published.

G-BA documents on this decision

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